Identity
- Trade Name
- ORTHO FDA UDI
- Generic Name
- Group A2 Rh (D) negative reagent red blood cell IVD, antigen FDA UDI
- Device Name
- Ortho® A2 Cells (Pooled Cells) FDA UDI
- Model / Reference
- 719310 FDA UDI
- Description
- Ortho® A2 Cells (Pooled Cells) FDA UDI
Identifiers
- Catalog Number
- 719310 FDA UDI
- Primary DI / UDI-DI
- 10758750003952 FDA UDI
- GMDN Term
- Group A2 Rh (D) negative reagent red blood cell IVD, antigen FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Group A2 Rh (D) negative reagent red blood cell IVD, antigen
Ortho by Ortho-Clinical Diagnostics — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Group A2 Rh (D) negative reagent red blood cell IVD, antigen.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Ortho-Clinical Diagnostics
Sources (1)
- FDA UDI 9b687f81-257e-44d2-8195-bf08679d0386 35 fields · synced May 30, 2026